Frequency of cisplatin administration in patients presenting with advanced urothelial carcinoma in the community.

2012 ◽  
Vol 30 (5_suppl) ◽  
pp. 285-285 ◽  
Author(s):  
Guru Sonpavde ◽  
Deidre Watson ◽  
Marcia Tourtellott ◽  
Erica Higgins ◽  
Charles Lance Cowey ◽  
...  
Keyword(s):  
Urothelial Carcinoma ◽  
Performance Status ◽  
Single Agent ◽  
Unmet Need ◽  
Poor Performance ◽  
Poor Performance Status ◽  
Cancer Centers ◽  
Ajcc Stage ◽  
Stage 4 ◽  
Advanced Urothelial Carcinoma

285 Background: Renal dysfunction, poor performance status, advanced age, and comorbidities may preclude standard frontline cisplatin-based chemotherapy in patients with advanced urothelial carcinoma (UC). We hypothesized that cisplatin-based regimens are not administered to the majority of patients in the community. A study was conducted to identify chemotherapy regimens administered by medical oncologists in community-based cancer centers. Methods: A retrospective study was conducted on patients with AJCC stage 4 UC presenting from 2001 to 2010 to Texas Oncology Cancer Centers. The frontline chemotherapy regimen was classified as cisplatin-based, carboplatin-based, non-platinum based and no chemotherapy administered. The association of age with administration of cisplatin was studied. Results: A total of 298 patients with stage 4 disease were eligible for this analysis out of 3574 patients with UC in this database. Of the 298 patients, 197 (66.1%) were male, the median age was 70 years (range 28-97), and the primary sites of disease were bladder (243, 81.5%), renal pelvis (41, 13.8%) and ureter (14, 4.7%). The regimens administered were cisplatin-based in 107 patients (35.9%), carboplatin-based in 81 (27.2%), non-platinum in 25 (8.4%), no chemotherapy was administered in 71 (23.8%) and data were not available in 14 patients (4.7%). Cisplatin administration appeared more common in patients aged ≤70 years (62 of 150, 41.3%) as opposed to >70 years (45 of 148, 30.4%), p=0.05. Non-cisplatin regimens or no chemotherapy were trending to be more commonly administered to patients >70 years (64.2 vs. 54.7%, p=0.10). Limitations of a retrospective database study apply and the reasons for not administering cisplatin are unclear. Conclusions: Cisplatin-based chemotherapy was administered to 35.9% of patients presenting with AJCC stage 4 UC to community cancer centers. Given that the majority of patients may not be cisplatin-eligible or candidates for chemotherapy, this population has a significant unmet need. Drug development focused on single agent therapy with tolerable, convenient and efficacious agents or combination regimens without a cisplatin backbone should be a priority.

Long-term follow-up of a phase III intergroup study of cisplatin alone or in combination with methotrexate, vinblastine, and doxorubicin in patients with metastatic urothelial carcinoma: a cooperative group study.

1997 ◽  
Vol 15 (7) ◽  
pp. 2564-2569 ◽  
Author(s):  
S B Saxman ◽  
K J Propert ◽  
L H Einhorn ◽  
E D Crawford ◽  
I Tannock ◽  
...  
Keyword(s):  
Urothelial Carcinoma ◽  
Combination Chemotherapy ◽  
Performance Status ◽  
Single Agent ◽  
Phase Iii ◽  
Long Term Follow Up ◽  
Intergroup Trial ◽  
Advanced Urothelial Carcinoma

PURPOSE A previously reported randomized intergroup trial demonstrated that combination chemotherapy with methotrexate, vinblastine, doxorubicin, and cisplatin (M-VAC) was superior to single-agent cisplatin in patients with advanced urothelial carcinoma. We conducted a long-term analysis of patients included in the intergroup trial to examine factors associated with long-term survival. PATIENTS AND METHODS Two-hundred fifty-five assessable patients with urothelial carcinoma were randomized to receive either single-agent cisplatin (70 mg/m2 on day 1) or combination chemotherapy with methotrexate (30 mg/m2 on days 1, 15, and 22), vinblastine (3 mg/m2 on days 2, 15, and 22), doxorubicin (30 mg/m2 on day 2), and cisplatin (70 mg/m2 on day 2). Courses were repeated every 28 days. The association between patient characteristics and survival was assessed using Cox proportional hazards models. RESULTS With long-term follow-up evaluation, survival in the M-VAC arm continues to be superior to cisplatin (P = .00015, log-rank test). Predictors of survival include performance status, histology, and the presence of liver or bone metastasis. Only 3.7% of the patients randomized to M-VAC are alive and continuously disease-free at 6 years. CONCLUSION Long-term follow-up evaluation of the intergroup trial confirms that M-VAC is superior to single-agent cisplatin in patients with advanced urothelial carcinoma; however, durable progression-free survival is rare. Patients with non-transitional-cell histology, poor performance status, and/or bone or visceral involvement fare poorly and are unlikely to benefit significantly from M-VAC chemotherapy.

scholarly journals Role of Stereotactic Body Radiotherapy in the Treatment of Elderly and Poor Performance Status Patients With Pancreatic Cancer

2017 ◽  
Vol 13 (3) ◽  
pp. 157-166 ◽  
Author(s):  
Lauren M. Rosati ◽  
Joseph M. Herman
Keyword(s):  
Pancreatic Cancer ◽  
Stereotactic Body Radiotherapy ◽  
Group Performance ◽  
Performance Status ◽  
Single Agent ◽  
Locally Advanced ◽  
Poor Performance ◽  
Tumor Control ◽  
Poor Performance Status ◽  
Patient Reported

Literature on the management of nonmetastatic pancreatic ductal adenocarcinoma in patients who are elderly or have poor performance status is sparse. The median survival of this unique cohort of patients is < 6 months, and most patients are only offered single-agent gemcitabine or supportive care. Recently, adding nanoparticle albumin-bound paclitaxel to gemcitabine was shown to improve survival of patients with metastatic disease with Eastern Cooperative Group performance status of 2. Although standard chemoradiotherapy provides long-term locoregional control in locally advanced pancreatic cancer, it is difficult for this group of patients to tolerate 6 weeks of therapy. Stereotactic body radiotherapy (SBRT) can be delivered in only 3 to 5 days, does not require concurrent chemotherapy, and has limited toxicity, and tumor control rates appear to be equivalent to or better than those achieved with standard chemoradiotherapy. Additionally, SBRT has been shown to improve cancer-related pain and patient-reported quality of life. Given the favorable toxicity profile, SBRT seems like an obvious choice for patients who are elderly, have multiple comorbidities, or have poor performance status. Herein, we review the literature on SBRT in this unique patient population and discuss future directions.

scholarly journals A Review of Docetaxel: Its Use in the Treatment of Gastric Cancer

2010 ◽  
Vol 2 ◽  
pp. CMT.S5191
Author(s):  
Alessandro Inno ◽  
Michele Basso ◽  
Alessandra Cassano ◽  
Carlo Barone
Keyword(s):  
Gastric Cancer ◽  
Phase Ii ◽  
Performance Status ◽  
Single Agent ◽  
Progression Free Survival ◽  
Poor Performance ◽  
Phase Iii ◽  
Poor Performance Status ◽  
Phase Ii Studies ◽  
Combination Regimens

Docetaxel, a member of the taxane family, promotes cell death by binding β-tubulin and has demonstrated activity against several human malignancies, both as a single agent and in combination therapy. It has been approved in Europe and the US as front-line treatment for advanced gastric cancer in combination with cisplatin and fluorouracil (DCF regimen). This approval was based on the results of a pivotal study (V325) which demonstrated that the addition of docetaxel to the reference regimen of cisplatin and fluorouracil improves overall survival and progression-free survival with a better quality of life despite increased toxicity (mainly haematological). Modifications of DCF regimen have been successfully investigated as a means of making the treatment more tolerable and suitable also for elderly patients or patients with poor performance status. Emerging data from several phase II studies suggest that other docetaxel-based combination regimens with anthracyclines or irinotecan have interesting activity with acceptable toxicity profiles, but the true efficacy of these regimens needs to be assessed in large randomized phase III studies. Thus, the best docetaxel-containing regimen has yet to be identified. Docetaxel also represents a good candidate for combination with novel molecular target agents. In light of the high response rates observed in phase II-III studies, a docetaxel-based chemotherapy regimen might also be considered a treatment option as perioperative or adjuvant therapy in potentially curable gastric cancer and further studies with or without biological agents are eagerly awaited in this setting.

Multimodality Treatment for Esophageal Malignancy: The Roles of Surgery and Neoadjuvant Therapy

2009 ◽  
Vol 75 (6) ◽  
pp. 489-497 ◽  
Author(s):  
Edward Malin ◽  
Paul D. Kiernan ◽  
Michael J. Sheridan ◽  
Sandeep J. Khandhar ◽  
Cheryl Fraser ◽  
...  
Keyword(s):  
Hospital Mortality ◽  
Performance Status ◽  
Single Agent ◽  
Survival Rates ◽  
Poor Performance ◽  
Multimodality Treatment ◽  
Stage I ◽  
Poor Performance Status ◽  
Esophageal Malignancy

The best curative treatment for esophageal malignancy remains controversial. In 2003, we presented our institution's experience with 124 patients treated from 1990 to 2001. Here we update that experience with an additional 6 years’ data. A total of 221 patients underwent surgical resection from 1990 to 2007; 128 had up-front surgery, 88 underwent surgery after neoadjuvant radiation and chemotherapy (NARCS), and five underwent surgery after neoadjuvant, single-agent therapy Principle outcomes of interest were 30-day and in-hospital mortality as well 3- and 5-year survival rates. Overall 3- and 5-year survival rates were 38 and 33 per cent. NARCS achieved complete pathologic result in 32 per cent of patients with corresponding 3- and 5-year survival rates of 58 and 53 per cent. The 3- and 5-year survival rates for all patients undergoing NARCS were 36 and 31 per cent versus 24 and 18 per cent for patients with up-front surgery for anything over Stage I disease ( P = 0.01). The 3- and 5-year survival rates for patients with up-front resection of Stage I disease were 78 and 70 per cent. Overall, 30-day and in-hospital mortalities were 1.8 and 2.3 per cent. Since January 1, 2000, hospital mortality has been less than 0.8 per cent. We prefer NARCS for malignancy of the esophagus, except in those patients with high-grade dysplasia (carcinoma in situ), suspected Stage I disease, poor performance status, or urgent/emergent circumstances.

Phase II trial of paclitaxel and carboplatin in the treatment of advanced urothelial carcinoma.

1998 ◽  
Vol 16 (5) ◽  
pp. 1844-1848 ◽  
Author(s):  
B G Redman ◽  
D C Smith ◽  
L Flaherty ◽  
W Du ◽  
M Hussain
Keyword(s):  
Urothelial Carcinoma ◽  
Performance Status ◽  
Single Agent ◽  
Area Under The Curve ◽  
Total Bilirubin Level ◽  
Median Response ◽  
Treatment Delays ◽  
Eligibility Requirements ◽  
Advanced Urothelial Carcinoma ◽  
Dose Reductions

PURPOSE Both paclitaxel and carboplatin have single-agent activity against carcinoma of the urothelium. We evaluated the combination of paclitaxel and carboplatin in the treatment of advanced cancers of the urothelium. PATIENTS AND METHODS Patients with cancers of the urothelium who had no prior chemotherapy (prior adjuvant chemotherapy > 6 months allowed) were eligible for treatment. Eligibility requirements were performance status of 2 or less, creatinine level less than 2.0 mg/dL, granulocyte count (AGC) 1,500/microL or greater, platelet count 100,000/microL or greater, and total bilirubin level less than 1.5 mg/dL. Paclitaxel 200 mg/m2 followed by carboplatin (area under the curve [AUC] 5, Calvert formula) were administered every 21 days. Patients were evaluated for toxicity weekly and assessed for response every 6 weeks. RESULTS Thirty-six patients were entered onto the study and 35 patients were assessable for response. A total of 184 cycles were administered (median, six cycles per patient). Nine patients required one dose reduction, and seven patients required two dose reductions for a nadir AGC less than 500/microL, with only one episode of febrile neutropenia and sepsis. Myalgias and arthralgias of grades 1 to 2 occurred in 16 patients and usually lasted 2 to 3 days after treatment. There were no treatment delays because of toxicity. There were 18 responses; seven complete responses (CRs) and 11 partial responses (PRs) (response rate 51.5%; 95% confidence interval, 35 to 68). Median response durations for CR and PR were 6 and 4 months, respectively. Overall median survival was 9.5 months. CONCLUSION The combination of paclitaxel and carboplatin is an active and well-tolerated regimen for the treatment of advanced urothelial carcinoma. Because of the modest toxicity of this combination, paclitaxel and carboplatin should be considered for addition to other agents with activity in urothelial carcinomas.

scholarly journals Short remission durations in therapy-related leukemia despite cytogenetic complete responses to high-dose cytarabine

Blood ◽  
1988 ◽  
Vol 72 (4) ◽  
pp. 1333-1339
Author(s):  
RA Larson ◽  
M Wernli ◽  
MM Le Beau ◽  
KM Daly ◽  
LH Pape ◽  
...  
Keyword(s):  
Complete Remission ◽  
Chromosomal Abnormalities ◽  
Bone Marrow Cells ◽  
Performance Status ◽  
Single Agent ◽  
Poor Performance ◽  
High Response Rate ◽  
Poor Performance Status ◽  
High Dose ◽  
High Dose Cytarabine

Seventeen patients with therapy-related myelodysplastic syndrome (t- MDS) or therapy-related acute nonlymphocytic leukemia (t-ANLL) were treated with single-agent high-dose cytarabine (HDAC; 1 to 3 g/m2 every 12 hours for 12 doses). The initial neoplasm was still present in eight patients when t-MDS/t-ANLL developed. Fifteen of the 16 patients with chromosomal abnormalities in bone marrow cells had loss or rearrangement of chromosomes 5 and/or 7. One patient had a t(15;17), and one had inadequate material for cytogenetic analysis. Twelve patients had normal metaphase cells (3% to 71%). Indications for HDAC therapy were progressive pancytopenia in 13 patients or rising blast count in four. Five patients died of marrow hypoplasia following therapy. Four others had refractory t-ANLL and died within the subsequent 5 months. Only one of ten patients with a poor performance status (PS greater than or equal to 2 using the ECOG scale) achieved a complete remission, but all seven patients with a good performance status (PS less than or equal to 1) had a complete remission. Hematologic remissions were achieved in 8 patients (47%) after one (6 patients) or two (2 patients) induction courses and were confirmed by recovery of a 100% normal marrow karyotype in six of the seven patients who were retested. Patients in remission received one to four consolidation courses with HDAC alternating with cytarabine/doxorubicin, but seven relapsed within 8 months (median remission duration, 5 months). In every case, the original chromosomal abnormality reappeared at relapse. HDAC has a high response rate for good-performance patients with t-MDS/t-ANLL, but complete remissions are short even when confirmed cytogenetically and consolidated intensively.

scholarly journals Analysis of a prospectively randomized comparison of doxorubicin versus 5-fluorouracil, doxorubicin, and BCNU in advanced gastric cancer: implications for future studies.

1986 ◽  
Vol 4 (9) ◽  
pp. 1348-1355 ◽  
Author(s):  
J A Levi ◽  
R M Fox ◽  
M H Tattersall ◽  
R L Woods ◽  
D Thomson ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
Performance Status ◽  
Single Agent ◽  
Locally Advanced ◽  
Poor Performance ◽  
Poor Performance Status ◽  
Measurable Disease ◽  
Duration Of Response ◽  
And Performance

A multi-institutional cooperative study of patients with locally advanced, recurrent, or metastatic gastric adenocarcinoma who had not previously received chemotherapy was conducted, prospectively randomizing patients to receive either doxorubicin or the three-drug combination, 5-fluorouracil (5-FU), doxorubicin (Adriamycin; Adria Laboratories, Columbus, Ohio), and BCNU (FAB). The 187 evaluable patients were initially stratified according to the presence of measurable or evaluable disease and performance status. There was a significantly higher response rate observed for FAB (40%) compared with doxorubicin (13%) among the 145 measurable-disease patients. Duration of response and survival were significantly longer for FAB in the measurable-disease group, but for the total patient population an early advantage for FAB in time to disease progression and survival was lost with continued follow-up. Median survival was 33 weeks for patients receiving FAB and 19 weeks for those receiving doxorubicin. Significant pretreatment factors adversely affecting survival included poor performance status, weight loss of greater than 10%, and more than two sites of metastases. Toxicity was not severe in either treatment arm, and only thrombocytopenia occurred significantly more often with FAB. It is contended that in the treatment of advanced gastric cancer, chemotherapy only exerts a relatively short-term and modest beneficial effect, most apparent in patients with intermediate tumor bulk. 5-FU remains the most active single agent, and combination chemotherapy has not yet proven its overall worth. Further studies are indicated comparing the most active combinations with 5-FU using optimal doses and schedules, and consideration must be given to the incorporation of no-treatment controls.

Nimotuzumab as a single agent palliative therapy in performance score 3 and above in EGFR expressing tumors.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e21635-e21635
Author(s):  
Suresh VS Attili ◽  
Dilip Pawar ◽  
Chinnababu Sunkavalli
Keyword(s):  
Solid Tumors ◽  
Performance Status ◽  
Single Agent ◽  
Palliative Therapy ◽  
Poor Performance ◽  
Median Number ◽  
Poor Performance Status ◽  
Induction Phase ◽  
Igg1 Monoclonal Antibody ◽  
Additional Chemotherapy

e21635 Background: Nimotuzumab is a humanized IgG1 monoclonal antibody against the EGFR extracellular domain that has been evaluated in solid tumors as a single agent or in combination with chemotherapy and radiation. However when used without radiation, its always used in adjunct to chemotherapy. With encouraging results of other EGFR monoclonal antibodies as single agent therapies, we explored the possibility of using Nimotuzumab as single agent by which we could avoid chemo related side effects. In view of the limited options availability for subjects with PS 3 and more we thought of choosing this population for analysis of Nimotuzumab as single agent palliative therapy in PS 3 and above EGFR expressing tumors for safety and efficacy Methods: Details of the 38 subjects with pre-treated advanced refractory or progressive solid tumors having PS of more than 2 were evaluated. Nimotuzumab was administered weekly at 200 mg/m2 as single agent for 4 weeks (induction phase) and patients were stratified into those with improved PS and those without. The subjects without PS improvement were continued on the single agent and those with improvement were offered additional chemotherapy . Nimotuzumab could be continued beyond disease progression. Results: Out of 38 patients, 18 had improvement in the PS and were offered chemotherapy later. 16 patients had stable PS and disease. 3 subjects were lost to follow up and 1 patient did not continued. The median number of nimotuzumab applications was 6 (2–11) in the induction phase and the median chemotherapy cycles were 3 (1-6). No toxicity occurred during induction phases (single agent nimotuzumab) and during chemotherapy the Grade II/IV toxicities were observed in 6 (33%) cases predominantly cytopeneas, neuropathy and diarrhea. The median PFS was 142 days (95% CI, 84 to 182), and the median improvement in QOL was 6 points on a scale of 30. Conclusions: Nimotuzumab is well tolerated and may have a role in the treatment of advanced cancers as a single agent in patients with poor performance status. 47% of the patients who are otherwise not eligible for chemo became eligible and had better QOL and longer PFS [compared to historical controls]

Gefitinb along with methotrexate as palliative therapy in PS 3 and above in metastatic esophagus squamous cell carcinoma with focus on Q-TWIST.

2020 ◽  
Vol 38 (4_suppl) ◽  
pp. 355-355
Author(s):  
VIDYA SAGAR DUSI ◽  
Obul Reddy C ◽  
Suresh VS Attili ◽  
Satya Dattatreya Palanki
Keyword(s):  
Squamous Cell Carcinoma ◽  
Cell Carcinoma ◽  
Squamous Cell ◽  
Performance Status ◽  
Single Agent ◽  
Palliative Therapy ◽  
Poor Performance ◽  
Median Number ◽  
Poor Performance Status ◽  
Metronomic Therapy

355 Background: Metronomic therapy is proven method for treatment of terminally ill patients with malignancy, who are not fit for chemotherapy. The median PFS was significantly superior in responders in previous Indian experiences. However most of them were done in head and neck cancers.The prognosis of patients with metastatic esophageal cancer remains poor with only option being symptomatic care. As the previous experiences show metronomic therapy is safe among various options and there is no study focusing on Quality-Adjusted Time Without Symptoms or Toxicity (Q-TWiST) in southern Indian population,we thought of evaluating the same. Methods: Details of 42 subjects with refractory or progressive metastatic squamous cell carcinoma esophagus having PS > 2 were evaluated. Case records between 2017 September and 2018 September were analyzed for TWIST and QOL. Patients received Gefitinib (250 mg/day), Methotrexate 15 mg IM weekly or in combination. Patients were stratified into those with improved PS and those without. The subjects without PS improvement were continued on the single agent and those with improvement were offered additional chemotherapy based on physician/ patient preference. Metronomic therapy could be continued beyond disease progression- if there is TWIST/QOL improvement. Results: Out of 42 subjects, 29 had improvement in the PS and were continued later. 9 had stable PS and disease. 4 had worsening of PS. 34 subjects have clinically meaningful response (stable disease + complete + partial responses) and had symptomatic improvement. The median number of cycles was 6 (4–11). The median PFS was 198 days (95% CI, 174 to 214), and the median improvement in QOL was 6 points on a scale of 25. Grade II/IV toxicities were observed in 21 (50%) cases predominantly skin rash, stomatitis and diarrhea. Conclusions: Metronomic therapy is well tolerated and may have a role in the treatment of advanced cancers with poor performance status. 67% of the patients who are otherwise not eligible for any active therapy became eligible and had better QOL and longer PFS, which re-emphasizes role of metronomic therapy in advanced squamous cell carcinoma of esophagus.

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